A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601

A Phase IV Clinical Trial to Evaluate the Preventive Effectiveness of NSAID-Associated Gastroduodenal Injury (Multi-center, Double-blind, Active-controlled, Stratified Randomized, Parallel Group)

Sponsors

Lead Sponsor: Dong-A ST Co., Ltd.

Source Dong-A ST Co., Ltd.
Brief Summary

This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.

Detailed Description

After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed.

Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.

Overall Status Completed
Start Date September 2012
Completion Date March 2014
Primary Completion Date March 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
the percentage of protected subjects (%) 4 weeks
Secondary Outcome
Measure Time Frame
A percentage of a protected subject (at duodenum), and of ulcer occurrence 4 weeks
Enrollment 520
Condition
Intervention

Intervention Type: Drug

Intervention Name: Stillen

Arm Group Label: Stillen

Intervention Type: Drug

Intervention Name: Cytotec (reference drug)

Arm Group Label: Cytotec

Intervention Type: Drug

Intervention Name: NSAID (Aceclofenac)

Eligibility

Criteria:

Inclusion Criteria:

- Need to take NSAID pills for longer than four weeks

- should be normal diagnosed by the endoscopy test

Exclusion Criteria:

- The patients have gastric ulcer or duodenal ulcer within 30 days

- The patients have a gastro-intestinal surgery within a year

- The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)

Gender: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: Inje University Busan Paik Hospital
Location Countries

Korea, Republic of

Verification Date

September 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Stillen

Type: Experimental

Description: Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID

Label: Cytotec

Type: Active Comparator

Description: The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov